510(k) · Cleared

Recalled · 2007

Aspen Ultrasound with Freestyle Imaging Option

K991805510(k) TraditionalCleared Aug 2, 199968-day reviewClass II21 CFR 892.1550Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Acuson Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 2, 1999 as substantially equivalent to K934915 (Acuson Corp., 1994) after a 68-day review. Its family tree reaches back 1 generation to 1994. 2 of the 1,095 devices in its family, counting itself, have a Class I recall. 1,093 later devices descend from it. It has been recalled once.

Decided: Aug 2, 1999
Review: 68 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K934915 (1994). 1,093 later devices descend from it, 6 citing it directly. 2 of the 1,095 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK934915 Acuson Model 2001Acuson Corp. · 1994
This deviceK991805 Aspen Ultrasound with Freestyle Imaging OptionAcuson Corp. · 1999
Descendant · cites it directly · 1,069 of its ownK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
Descendant · 2 generations on · 1,003 of its ownK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
Descendant · 3 generations on · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
Descendant · 4 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · 5 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005

Showing 5 of 1,093 descendants. See all descendants

Descendants cleared per year

2001high 86 (2025) · low 1 (2002)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System12 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System12 generations on · 2025

Most influential descendants

Showing 5 of 1,093 · See all

K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002 · cites it directly1,069descendants
K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on1,003descendants
K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on988descendants
K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 4 generations on979descendants
K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 5 generations on972descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934915	Acuson Model 2001	Acuson Corp.	1994	—
0 (this device)	K991805	Aspen Ultrasound with Freestyle Imaging Option	Acuson Corp.	1999	—
+1	K022567	Sequoia Signature II Diagnostic Ultrasound System	Acuson Corp.	2002	—
+2	K032114	Sequoia 8.0 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2003	—
+3	K041319	Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
+4	K051139	Acuson Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+5	K052410	Acuson Sequoia Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2002	1	0
2003	5	0
2004	13	0
2005	14	0
2006	13	0
2007	18	0
2008	20	0
2009	23	0
2010	24	0
2011	34	0
2012	40	0
2013	45	0
2014	54	0
2015	62	0
2016	65	0
2017	78	0
2018	69	0
2019	50	0
2020	78	0
2021	56	0
2022	61	0
2023	61	0
2024	66	0
2025	86	2
2026	55	0

FIG. 1 — Lineage of K991805, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K934915	Acuson Model 2001 Summary page 1 …uses. III. DEVICE DESCRIPTION The Aspen Ultrasound System with the FreeStyle feature is a modification of the Aspen Ultrasound System previously cleared as Model 2001, K934915/S1. The FreeStyle feature allows visualization of anatomy over a wider field of view that surrounds a particular region of intere…	Acuson Corp.	1994	—

Also cleared against K934915: 1 other device →

What descends from it? (1,093)

See all 1,093

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022567	Sequoia Signature II Diagnostic Ultrasound System	Acuson Corp.	2002	1,069
K012191	Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes	Teratech Corp.	2001	25
K040840	Teratech Model 10V5 Smart Probe	Teratech Corp.	2004	2
K013849	Tetrad Model TC-EC7-Acp, -L5-, -L7-, -V4-Acp Transducers	Tetrad Corp.	2001	1
K040213	MHLX7EC Transducer	Microhelix, Inc.	2004	0
K040409	Larsen & Toubro Limited Senorita Color Doppler Ultrasound System	Larsen & Toubro Limited	2004	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 18, 2007	Not classified	Z-1107-2004	Software design	Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K022567 (Acuson Corp., 2002) has gone furthest, with 1,069 descendants of its own.
1 other device also cites its predicate K934915.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

What is it indicated for?

The Aspen Ultrasound System with the FreeStyle option provides B-mode images of anatomy in

a field of view that extends well beyond a conventional B-mode region of interest. The FreeStyle

option can also provide qualitative Color flow information in this extended field of view. The

indications for use for each transducer operating with the FreeStyle feature are unchanged and

include fetal, small organ, peripheral vessel, abdominal, gynecologic, transrectal, intraoperative,

and musculoskeletal uses.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991805 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991805: Aspen Ultrasound with Freestyle Imaging Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991805

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026